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HOT TOPIC: New NIH “Clinical Trials” Definition to Impact Basic Social and Behavioral Science Research

Hot Topic LogoThe National Institutes of Health (NIH) has been working for the last few years to enhance its stewardship of and increase transparency over the clinical trials it funds. The agency, which is the largest funder of clinical trials in the U.S., issued a Notice of Revised NIH Definition of “Clinical Trial” (NOT-OD-15-015) in late 2014 laying out a new, expanded definition to govern which research projects are to be categorized as a “clinical trial” from here on out.

While this change has been in process for the last few years, it wasn’t until more recently that the biomedical and behavioral research community started to take notice of the potentially significant impacts this new definition could have on a variety of basic research activities funded by the NIH, which will now be considered clinical trials. Although it was developed with the traditional NIH biomedical research clinical trial in mind and in response to concerns about study results going unreported, the social and behavioral sciences are impacted as well.

The 2016 notice states that “the revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.” While it further states that the intention is not to “expand the scope of the category of clinical trials,” the resulting policy does just that.

Read on for COSSA’s full analysis of the changes.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

HOT TOPIC: HHS Announces Final Changes to Human Subjects Research Regulations

During the final days of the Obama Administration, the U.S. Department of Health and Human Services (HHS) released the final text for its changes to the Common Rule, the regulations that govern research with human subjects, completing a revision process started in 2011. The Common Rule, which was last updated in 1991, affects research supported by 16 federal departments and agencies, including the Departments of Health and Human Services, Agriculture, Defense, Education, Commerce, Labor, and Veterans Affairs, as well as the National Science Foundation.

Overall, the changes look to be a positive development for the social and behavioral science research community. According to the executive summary, “The final rule is designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies such as behavioral and social science research.” The rule maintains several proposals from the earlier Notice of Proposed Rulemaking (NPRM) that aimed to reduce the oversight burden on researchers conducting studies that pose no or minimal risk to participants (like a lot of social and behavioral science research). It also declines to adopt several provisions that were controversial in the biomedical research community (although supported by some in the social sciences), including consent requirements surrounding work with de-identified biospecimens, which is likely to lead to a less contentious reception overall.

Read on for COSSA’s full analysis of the changes.

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Posted in Issue 2 (January 24), Update, Volume 36 (2017)

House Subcommittee Holds Hearing on Academic Research Regulatory Relief

The Subcommittee on Research and Technology of the House Committee on Science, Space, and Technology held a hearing on September 29 to review recommendations related to regulatory relief for academic research. Rep. Barbra Comstock (R-VA), the Subcommittee Chair, and Rep. Daniel Lipinski (D-IL), the Ranking Member, have both introduced legislation to help ease the administrative burden on federally-funded researchers. The hearing highlighted a report from the Government Accountability Office (GAO) that provides recommendations to the Department of Energy, NASA, the Department of Health and Human Services, and the National Science Foundation on how to streamline administrative requirements. Witnesses included John Neumann of the GAO; Dr. Larry Faulkner, President Emeritus of the University of Texas at Austin; Jim Luther, Associate Vice President for Finance and Compliance Officer at Duke University; and Dr. Angel Cabrera, the President of George Mason University.
See COSSA’s Hot Topics piece for more information and analysis about the efforts to reduce the administrative burden on federally-funded researchers.
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Posted in Issue 19 (October 4), Update, Volume 35 (2016)

HOT TOPIC: Reducing the Regulatory Burden on Federally-Funded Researchers

COSSA has released a new publication in its HOT TOPICS series, Reducing the Regulatory Burden on Federally-Funded Researchers. HOT TOPICS are periodic, featured articles prepared by COSSA staff members offering insights into timely issues important to the social and behavioral science community. This edition was written by Camille Hosman, who joined the COSSA team earlier this year.

The report provides an overview of some of the major efforts made in recent years to better understand issues of regulatory burden and to begin to develop roadmaps for addressing it. While there is no shortage of ideas, given the complexity of the topic and the many players– federal agencies, Congress, research institutions, and researchers themselves– the path to relief is less clear. Read on for the full report.

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Posted in Issue 16 (August 9), Update, Volume 35 (2016)

HOT TOPIC: Scientific Organizations Reflect on Building “Trust in Science”

By Julia Milton, COSSA

The scientific community has been grappling with topics related to science communication and public trust in science lately. This spring, several major scientific organizations met to focus on these issues. To name a few, the National Academy of Science’s 2015 Henry and Bryna David Lecture was held on “Communicating the Value and Values of Science;” the AAAS’ annual Forum on Science and Technology Policy held not one, but two break-out sessions on “Public Opinion and Policy Making,” as well as an evening plenary lecture entitled “Science to Action: Thoughts on Convincing a Skeptical Public;” and the Academies’ Roundtable on Public Interfaces of the Life Sciences held a workshop, “Does the Public Trust Science? Trust and Confidence at the Intersections of the Life Sciences and Society.”

According to Pew Research Associate Director Cary Funk, the public generally has confidence in both the institution of science and scientists as a profession. However, when it comes to specific science-related issues like evolution, attitudes become more varied and may be correlated with factors like political ideology, education, and religiosity, depending on the topic. There is certainly a sense that “science” has been on the defensive lately as public policy debates on climate change, childhood vaccinations, and genetically modified foods generate controversy and incidents like the high-profile retraction of a study on attitudes toward same-sex marriage grab headlines. (more…)

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Posted in Issue 11 (June 16), Update, Volume 34 (2015)

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